Enhancing competency in clinical trials management: Findings from a multicountry trial coordinators’ interventional training program

Abstract Background Clinical research coordinators play a crucial role in ensuring the scientific rigor, regulatory compliance, and operational integrity of clinical trials. However, in Africa, they often lack access to structured, competency-based training, especially in operational, regulatory, and trial management domains. This study evaluated the effectiveness of a comprehensive training intervention designed to standardize and enhance core competencies of clinical trial coordinators. Methods We conducted a prospective pre-post interventional study among cohorts of clinical research professionals completing a 10-week, internationally-accredited, Moodle-based clinical trial operations training program aligned with the Joint Task Force Core Competency Framework, covering 10 lessons and 25 domains. Self-reported competence was evaluated at baseline and post-training. Data analyses included paired t-tests for aggregate scores, McNemar’s exact test for domain-level proportions, multivariable logistic regression for predictors of improvement, and Cohen’s d for effect size. Results Among the 166 participants enrolled from 19 African countries and completed the pre-training survey, 152 who completed the program and post-training survey were included. The training significantly increased the mean aggregate competence from 12.24±7.85 (out of a maximum of 25) to 23.35±2.73 (mean difference: 11.11; 95% CI 9.86-12.36; p